The Payor Guidance sets forth FDA's current position on manufacturer-payor communications, and, in particular, FDAMA 114 and communications related to healthcare economic information (HCEI) with payors across a product's lifecycle, providing recommendations to firms to help them ensure that their HCEI and other communications to payors are truthful and non-misleading and that appropriate background and contextual information is provided to enable payors to make informed decisions. issued a press release announcing the final guidance documents as part of the Agency's "new efforts to advance medical product communications to support drug competition and value-based health care." Citing the Trump Administration's Drug Pricing blueprint, which we summarized here, Commissioner Gottlieb emphasized "the importance of linking payments for drugs to their value" and "removing regulatory obstacles to value-based purchasing by payors." To achieve these goals, Commissioner Gottlieb acknowledged the need for FDA to provide "clear guidance to pharmaceutical companies about open, responsible communication with payors, formulary committees and others." With respect to the CFL Guidance, Commissioner Gottlieb emphasized that the guidance will facilitate the sharing of information, such as post-market study data, that "may help inform decision-making regarding patient care." Commissioner Gottlieb noted that FDA believes the two guidance documents "will provide clarity to companies as they develop communications about their medical products and help ensure that patients, providers and insurers have access to a range of relevant, truthful and non-misleading information from companies about medical products." The Payor Guidance Industry and other stakeholders have eagerly anticipated the revisions to these final guidance documents, which provide additional flexibility for manufacturers to communicate information not contained in a product labeling and which provide FDA's views on manufacturer communications with payors, including under Section 502(a) of the Federal Food, Drug, and Cosmetic Act as amended by Section 3037 of the 21st Century Cures Act (Section 114 of the Food and Drug Administration Modernization Act (FDAMA 114)).įDA Commissioner Scott Gottlieb, M.D. FDA published draft versions of these documents in January 2017, which we previously summarized here and here.Ĭomments on the guidance documents must be submitted to FDA by July 13, 2018. On June 12, 2018, the US Food and Drug Administration (FDA) issued revised, final versions of two guidance documents, "Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities-Questions and Answers" 1 (hereafter the "Payor Guidance") and "Medical Product Communications That Are Consistent With the FDA-Required Labeling-Questions and Answers" 2 (designated by FDA as the "CFL Guidance").
0 kommentar(er)
